In a vial filling room, filling zone was covered by LAF but the hopper was located out side the LAF due to some reasons. And media fill was successfully conducted in such way. Now an additional hanging LAF is going to be installed covering the hopper through change control procedure. In such case, is it mandatory to conduct media fill validation again ?
Hİ,
As I understand, you are adding an additional LAF to improve the existing condition. Unfortunately, the authority recommends us to fill Media after significant changes since there is a possibility of disrupting other conditions while making an additional improvement.
See Annex-1 / 9.49 İİ. There is a change to the process, equipment, procedures or environment that has the potential to affect the aseptic process or an addition of new product containers or container closure combinations.
See Annex-1 / 9.38 APS should be performed as part of the initial validation, with at least three consecutive satisfactory simulation tests that cover all working shifts that the aseptic process may occur, and after any significant modification to operational practices, facilities, services or equipment which are assessed to have an impact on the sterility assurance of the product (e.g. modification to the HVAC system, equipment, changes to process, number of shifts and numbers of personnel, major facility shut down)…
My suggestion to you is to make this change before the media fill that is done every 6 months.